US filing for Amgen's secondary hyperparathyroidism drug

Amgen has filed etelcalcetide with the US Food and Drug Administration for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease receiving haemodialysis.

Secondary HPT is a common, serious and often progressive condition among patients with CKD. It develops in response to declining kidney function, when the parathyroid (PTH) glands increase the production of thyroid to maintain normal levels of calcium and phosphorus.

However, eventually this excess production is not enough to maintain normal levels, and at the point of CKD dialysis, this manifests as abnormal amounts of PTH, calcium and phosphorus that, in turn, can lead to significant clinical consequences, such as weakness and thinning of the bones.

Etelcalcetide is a novel calcimimetic agent that suppresses the secretion of PTH by binding to and activating the calcium-sensing receptor on the parathyroid gland. The treatment is given intravenously three times per week at the end of each dialysis session.

The submission includes data from three Phase III studies, one of which showed that 74% of patients given the drug experienced a greater than 30% reduction from baseline in PTH compared with 8.3% in the placebo arm.

The development project, which began in 2011 after Amgen picked up the site from Pfizer, saw construction of an 11,500 square metre production plant, a new 5,800 square meter cold chain warehouse, and a significant revamp of existing buildings.